ID

43375

Description

ODM derived from http://clinicaltrials.gov/show/NCT00534287

Link

http://clinicaltrials.gov/show/NCT00534287

Keywords

Versions (3)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00534287 Severe Sepsis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

Age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Severe sepsis or septic shock according to ACCP/SCCM criteria
Description

Severe sepsis or septic shock according to ACCP/SCCM criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C1719672
ICD-10-CM Version 2010
R65.2
ICD-9-CM Version 2011
995.92
UMLS CUI 2011AA
C0036983
SNOMED CT 2011_0131
76571007
MedDRA 14.1
10040070
ICD-9-CM Version 2011
785.52
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1706462
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0557806
SNOMED CT 2011_0131
224864007
UMLS CUI 2011AA
C0586857
SNOMED CT 2011_0131
309345004
UMLS CUI 2011AA
C0037459
UMLS CUI 2011AA
C1319411
SNOMED CT 2011_0131
408478003
UMLS CUI 2011AA
CL414621
Onset of severe sepsis or septic shock <24 h
Description

Onset of severe sepsis or septic shock <24 h

Data type

boolean

Alias
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C1719672
ICD-10-CM Version 2010
R65.2
ICD-9-CM Version 2011
995.92
UMLS CUI 2011AA
C0036983
SNOMED CT 2011_0131
76571007
MedDRA 14.1
10040070
ICD-9-CM Version 2011
785.52
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
Informed Consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Effective contraception in fertile women
Description

Effective contraception in fertile women

Data type

boolean

Alias
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL426012
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Age <18 years
Description

Age <18 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Pregnancy, Gestation
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Breast feeding, Nursing
Description

Breast-feeding women

Data type

boolean

Alias
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Pretreatment with meropenem, imipenem, or ertapenem within the last 4 weeks (>1 daily dosage)
Description

Pretreatment with meropenem, imipenem, or ertapenem within the last 4 weeks (>1 daily dosage)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0066005
SNOMED CT 2011_0131
387540000
LOINC Version 232
MTHU008102
UMLS CUI 2011AA
C0020933
SNOMED CT 2011_0131
46558003
LOINC Version 232
MTHU007072
UMLS CUI 2011AA
C1120106
SNOMED CT 2011_0131
396346003
LOINC Version 232
MTHU016193
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C2348070
Pretreatment with moxifloxacin,ciprofloxacin, or levofloxacin within the last 4 weeks (>1 daily dosage)
Description

Pretreatment with moxifloxacin,ciprofloxacin, or levofloxacin within the last 4 weeks (>1 daily dosage)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0536495
SNOMED CT 2011_0131
412439003
LOINC Version 232
MTHU014635
UMLS CUI 2011AA
C0008809
SNOMED CT 2011_0131
372840008
LOINC Version 232
MTHU004599
UMLS CUI 2011AA
C0282386
SNOMED CT 2011_0131
387552007
LOINC Version 232
MTHU009097
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C2348070
Pretreatment with a pseudomonas effective cephalosporin (cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (>1 daily dosage).
Description

Pretreatment with a pseudomonas effective cephalosporin (cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (>1 daily dosage).

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0033808
SNOMED CT 2011_0131
57032008
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
UMLS CUI 2011AA
C2266959
SNOMED CT 2011_0131
373262009
UMLS CUI 2011AA
C0055003
SNOMED CT 2011_0131
96048006
LOINC Version 232
MTHU008443
UMLS CUI 2011AA
C0007559
SNOMED CT 2011_0131
387200005
LOINC Version 232
MTHU003920
UMLS CUI 2011AA
C0062986
SNOMED CT 2011_0131
387533001
LOINC Version 232
MTHU008447
UMLS CUI 2011AA
C0031955
SNOMED CT 2011_0131
372836004
LOINC Version 232
MTHU008471
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C2348070
Pretreatment with other chinolones within the last 4 weeks (>1 daily dosage)
Description

Pretreatment with other chinolones within the last 4 weeks (>1 daily dosage)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0034428
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C2348070
Presence of infection where guidelines recommend another antimicrobial therapy than the study medication (i.e. endocarditis)
Description

Presence of infection where guidelines recommend another antimicrobial therapy than the study medication (i.e. endocarditis)

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0220845
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0338237
SNOMED CT 2011_0131
281789004
MedDRA 14.1
10067768
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0014118
SNOMED CT 2011_0131
56819008
MedDRA 14.1
10014665
ICD-9-CM Version 2011
424.90
Evidence or strong clinical suspicion of a microorganism where the study medication is known to be ineffective (i.e. tuberculosis, MRSA- or VRE-infection)
Description

Evidence or strong clinical suspicion of a microorganism where the study medication is known to be ineffective (i.e. tuberculosis, MRSA- or VRE-infection)

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0442821
SNOMED CT 2011_0131
260404005
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0242114
UMLS CUI 2011AA
C0445623
SNOMED CT 2011_0131
264395009
LOINC Version 232
MTHU019420
HL7 V3 2006_05
MIC
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
UMLS CUI 2011AA
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.1
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
UMLS CUI 2011AA
C0343401
SNOMED CT 2011_0131
266096002
MedDRA 14.1
10021839
ICD-9-CM Version 2011
041.12
UMLS CUI 2011AA
C1265175
SNOMED CT 2011_0131
113727004
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Known allergy against meropenem or moxifloxacin
Description

Known allergy against meropenem or moxifloxacin

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0066005
SNOMED CT 2011_0131
387540000
LOINC Version 232
MTHU008102
UMLS CUI 2011AA
C0536495
SNOMED CT 2011_0131
412439003
LOINC Version 232
MTHU014635
Tendon disease or injury due to past quinolone therapy
Description

Tendon disease or injury due to past quinolone therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0039504
SNOMED CT 2011_0131
240037007
MedDRA 14.1
10043242
UMLS CUI 2011AA
C1280538
SNOMED CT 2011_0131
256667004
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0034428
Congenital or acquired prolongation of QT-interval
Description

Congenital or acquired prolongation of QT-interval

Data type

boolean

Alias
UMLS CUI 2011AA
C0009678
UMLS CUI 2011AA
C0439661
SNOMED CT 2011_0131
255396000
UMLS CUI 2011AA
C0151878
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
Concomitant medication which prolongs the QT-interval
Description

Concomitant medication which prolongs the QT-interval

Data type

boolean

Alias
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
C0151878
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
Electrolyte imbalance, especially uncorrected hypokalemia
Description

Electrolyte imbalance, especially uncorrected hypokalemia

Data type

boolean

Alias
UMLS CUI 2011AA
CL354536
UMLS CUI 2011AA
C0020621
SNOMED CT 2011_0131
43339004
MedDRA 14.1
10021015
ICD-10-CM Version 2010
E87.6
ICD-9-CM Version 2011
276.8
CTCAE 1105E
E12327
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1947976
Clinically relevant bradycardia
Description

Clinically relevant bradycardia

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0428977
SNOMED CT 2011_0131
48867003
MedDRA 14.1
10006093
ICD-10-CM Version 2010
R00.1
Clinically relevant cardiac dysfunction with reduced left-ventricular ejection fraction
Description

Clinically relevant cardiac dysfunction with reduced left-ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
UMLS CUI 2011AA
C1096403
MedDRA 14.1
10053222
Symptomatic arrhythmias in the medical history
Description

Symptomatic arrhythmias in the medical history

Data type

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0262926
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
Significant hepatic impairment (Child-Pugh C) or elevation of liver enzymes >5x the upper normal range
Description

Significant hepatic impairment (Child-Pugh C) or elevation of liver enzymes >5x the upper normal range

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0948807
MedDRA 14.1
10052254
UMLS CUI 2011AA
C4050412
UMLS CUI 2011AA
C0857093
MedDRA 14.1
10014480
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0086715
SNOMED CT 2011_0131
260395002
No commitment to full patient support (i.e. DNR order)
Description

No commitment to full patient support (i.e. DNR order)

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0026528
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1521721
UMLS CUI 2011AA
C0079252
Patient's death is considered imminent due to coexisting disease
Description

Patient's death is considered imminent due to coexisting disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C2363727
MedDRA 14.1
10068311
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0243087
Concomitant participation in another study or study participation within the last 30 days.
Description

Concomitant participation in another study or study participation within the last 30 days.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Relationship of the patient to study team member (i.e. colleague, relative)
Description

Relationship of the patient to study team member (i.e. colleague, relative)

Data type

boolean

Alias
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1552089
HL7 V3 2006_05
STF
UMLS CUI 2011AA
C0080103
SNOMED CT 2011_0131
125677006
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
Age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Severe sepsis or septic shock according to ACCP/SCCM criteria
Item
Severe sepsis or septic shock according to ACCP/SCCM criteria
boolean
C1719672 (UMLS CUI 2011AA)
R65.2 (ICD-10-CM Version 2010)
995.92 (ICD-9-CM Version 2011)
C0036983 (UMLS CUI 2011AA)
76571007 (SNOMED CT 2011_0131)
10040070 (MedDRA 14.1)
785.52 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1706462 (UMLS CUI 2011AA)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0586857 (UMLS CUI 2011AA)
309345004 (SNOMED CT 2011_0131)
C0037459 (UMLS CUI 2011AA)
C1319411 (UMLS CUI 2011AA)
408478003 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Onset of severe sepsis or septic shock <24 h
Item
Onset of severe sepsis or septic shock <24 h
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C1719672 (UMLS CUI 2011AA)
R65.2 (ICD-10-CM Version 2010)
995.92 (ICD-9-CM Version 2011)
C0036983 (UMLS CUI 2011AA)
76571007 (SNOMED CT 2011_0131)
10040070 (MedDRA 14.1)
785.52 (ICD-9-CM Version 2011)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Informed consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI 2011AA)
Effective contraception in fertile women
Item
Effective contraception in fertile women
boolean
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL426012 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Age <18 years
Item
Age <18 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pregnancy
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Breast-feeding women
Item
Breast feeding, Nursing
boolean
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Pretreatment with meropenem, imipenem, or ertapenem within the last 4 weeks (>1 daily dosage)
Item
Pretreatment with meropenem, imipenem, or ertapenem within the last 4 weeks (>1 daily dosage)
boolean
C1514463 (UMLS CUI 2011AA)
C0066005 (UMLS CUI 2011AA)
387540000 (SNOMED CT 2011_0131)
MTHU008102 (LOINC Version 232)
C0020933 (UMLS CUI 2011AA)
46558003 (SNOMED CT 2011_0131)
MTHU007072 (LOINC Version 232)
C1120106 (UMLS CUI 2011AA)
396346003 (SNOMED CT 2011_0131)
MTHU016193 (LOINC Version 232)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Pretreatment with moxifloxacin,ciprofloxacin, or levofloxacin within the last 4 weeks (>1 daily dosage)
Item
Pretreatment with moxifloxacin,ciprofloxacin, or levofloxacin within the last 4 weeks (>1 daily dosage)
boolean
C1514463 (UMLS CUI 2011AA)
C0536495 (UMLS CUI 2011AA)
412439003 (SNOMED CT 2011_0131)
MTHU014635 (LOINC Version 232)
C0008809 (UMLS CUI 2011AA)
372840008 (SNOMED CT 2011_0131)
MTHU004599 (LOINC Version 232)
C0282386 (UMLS CUI 2011AA)
387552007 (SNOMED CT 2011_0131)
MTHU009097 (LOINC Version 232)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Pretreatment with a pseudomonas effective cephalosporin (cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (>1 daily dosage).
Item
Pretreatment with a pseudomonas effective cephalosporin (cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (>1 daily dosage).
boolean
C1514463 (UMLS CUI 2011AA)
C0033808 (UMLS CUI 2011AA)
57032008 (SNOMED CT 2011_0131)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C2266959 (UMLS CUI 2011AA)
373262009 (SNOMED CT 2011_0131)
C0055003 (UMLS CUI 2011AA)
96048006 (SNOMED CT 2011_0131)
MTHU008443 (LOINC Version 232)
C0007559 (UMLS CUI 2011AA)
387200005 (SNOMED CT 2011_0131)
MTHU003920 (LOINC Version 232)
C0062986 (UMLS CUI 2011AA)
387533001 (SNOMED CT 2011_0131)
MTHU008447 (LOINC Version 232)
C0031955 (UMLS CUI 2011AA)
372836004 (SNOMED CT 2011_0131)
MTHU008471 (LOINC Version 232)
C1517741 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Pretreatment with other chinolones within the last 4 weeks (>1 daily dosage)
Item
Pretreatment with other chinolones within the last 4 weeks (>1 daily dosage)
boolean
C1514463 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0034428 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Presence of infection where guidelines recommend another antimicrobial therapy than the study medication (i.e. endocarditis)
Item
Presence of infection where guidelines recommend another antimicrobial therapy than the study medication (i.e. endocarditis)
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0220845 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0338237 (UMLS CUI 2011AA)
281789004 (SNOMED CT 2011_0131)
10067768 (MedDRA 14.1)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0014118 (UMLS CUI 2011AA)
56819008 (SNOMED CT 2011_0131)
10014665 (MedDRA 14.1)
424.90 (ICD-9-CM Version 2011)
Evidence or strong clinical suspicion of a microorganism where the study medication is known to be ineffective (i.e. tuberculosis, MRSA- or VRE-infection)
Item
Evidence or strong clinical suspicion of a microorganism where the study medication is known to be ineffective (i.e. tuberculosis, MRSA- or VRE-infection)
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0442821 (UMLS CUI 2011AA)
260404005 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0242114 (UMLS CUI 2011AA)
C0445623 (UMLS CUI 2011AA)
264395009 (SNOMED CT 2011_0131)
MTHU019420 (LOINC Version 232)
MIC (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
C0343401 (UMLS CUI 2011AA)
266096002 (SNOMED CT 2011_0131)
10021839 (MedDRA 14.1)
041.12 (ICD-9-CM Version 2011)
C1265175 (UMLS CUI 2011AA)
113727004 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Known allergy against meropenem or moxifloxacin
Item
Known allergy against meropenem or moxifloxacin
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0066005 (UMLS CUI 2011AA)
387540000 (SNOMED CT 2011_0131)
MTHU008102 (LOINC Version 232)
C0536495 (UMLS CUI 2011AA)
412439003 (SNOMED CT 2011_0131)
MTHU014635 (LOINC Version 232)
Tendon disease or injury due to past quinolone therapy
Item
Tendon disease or injury due to past quinolone therapy
boolean
C0039504 (UMLS CUI 2011AA)
240037007 (SNOMED CT 2011_0131)
10043242 (MedDRA 14.1)
C1280538 (UMLS CUI 2011AA)
256667004 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0034428 (UMLS CUI 2011AA)
Congenital or acquired prolongation of QT-interval
Item
Congenital or acquired prolongation of QT-interval
boolean
C0009678 (UMLS CUI 2011AA)
C0439661 (UMLS CUI 2011AA)
255396000 (SNOMED CT 2011_0131)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
Concomitant medication which prolongs the QT-interval
Item
Concomitant medication which prolongs the QT-interval
boolean
C2347852 (UMLS CUI 2011AA)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
Electrolyte imbalance, especially uncorrected hypokalemia
Item
Electrolyte imbalance, especially uncorrected hypokalemia
boolean
CL354536 (UMLS CUI 2011AA)
C0020621 (UMLS CUI 2011AA)
43339004 (SNOMED CT 2011_0131)
10021015 (MedDRA 14.1)
E87.6 (ICD-10-CM Version 2010)
276.8 (ICD-9-CM Version 2011)
E12327 (CTCAE 1105E)
C1518422 (UMLS CUI 2011AA)
C1947976 (UMLS CUI 2011AA)
Clinically relevant bradycardia
Item
Clinically relevant bradycardia
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0428977 (UMLS CUI 2011AA)
48867003 (SNOMED CT 2011_0131)
10006093 (MedDRA 14.1)
R00.1 (ICD-10-CM Version 2010)
Clinically relevant cardiac dysfunction with reduced left-ventricular ejection fraction
Item
Clinically relevant cardiac dysfunction with reduced left-ventricular ejection fraction
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C1522601 (UMLS CUI 2011AA)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C1096403 (UMLS CUI 2011AA)
10053222 (MedDRA 14.1)
Symptomatic arrhythmias in the medical history
Item
Symptomatic arrhythmias in the medical history
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
Significant hepatic impairment (Child-Pugh C) or elevation of liver enzymes >5x the upper normal range
Item
Significant hepatic impairment (Child-Pugh C) or elevation of liver enzymes >5x the upper normal range
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
C4050412 (UMLS CUI 2011AA)
C0857093 (UMLS CUI 2011AA)
10014480 (MedDRA 14.1)
CL384738 (UMLS CUI 2011AA)
C0086715 (UMLS CUI 2011AA)
260395002 (SNOMED CT 2011_0131)
No commitment to full patient support (i.e. DNR order)
Item
No commitment to full patient support (i.e. DNR order)
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0026528 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1521721 (UMLS CUI 2011AA)
C0079252 (UMLS CUI 2011AA)
Patient's death is considered imminent due to coexisting disease
Item
Patient's death is considered imminent due to coexisting disease
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C2363727 (UMLS CUI 2011AA)
10068311 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0243087 (UMLS CUI 2011AA)
Concomitant participation in another study or study participation within the last 30 days.
Item
Concomitant participation in another study or study participation within the last 30 days.
boolean
CL415222 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Relationship of the patient to study team member (i.e. colleague, relative)
Item
Relationship of the patient to study team member (i.e. colleague, relative)
boolean
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1552089 (UMLS CUI 2011AA)
STF (HL7 V3 2006_05)
C0080103 (UMLS CUI 2011AA)
125677006 (SNOMED CT 2011_0131)
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